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NCT01871155 Clinical Trial

Effect of Nutri-jelly on Quality of Life in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:
Efficacy Study of Nutri-jelly Intake on Quality of Life in Head and Neck Cancer Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01871155
Other study ID # DIF-01
Secondary ID
Status Completed
Phase N/A
First received May 30, 2013
Last updated June 4, 2013
Start date January 2012
Est. completion date August 2012

Study information
Verified date June 2013
Source Dental Innovation Foundation Under Royal Patronage
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.

Description:

- independent variable: continuous Nutri -jelly intake

- dependent variable (outcome): changes in health-related quality of life score

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria:

- diagnosed as head and neck cancer

- definitive or palliative radiotherapy treatment plan

- can communicate well

Exclusion Criteria:

- bleeding in the mouth

- respiratory distress

- psychiatric disorders

- radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Nutri-jelly
an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal 1 serving is considered as food supplement

Locations
Country Name City State
Thailand Mahavachiralongkorn cancer hospital Pathumthani

Sponsors (5)
Lead Sponsor Collaborator
Dental Innovation Foundation Under Royal Patronage Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University, Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Health-related quality of life score Definitive cases: collect data at baseline (0-5), after Nutri-jelly (6-10), 11-15, 16-20, 21-25, 26-30, 31-35 fractions of RT), total period of 6 weeks
Palliative cases: collect data at baseline (0-5), after Nutri-jelly (6-10) fractions of RT, total period of 2 weeks		 0, 1, 2, 3, 4, 5, 6 weeks after radiotherapy No
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